External Infusion Pumps

POLICY NUMBER

L.1.01.407

DESCRIPTION

An external infusion pump (EIP) is a portable device intended to provide continuous ambulatory drug infusion therapy over an extended time period. The EIP is also known as an external pump, ambulatory pump, or a mini-infuser. The EIP is usually the size of a portable cassette player and can be worn on a belt around the patient's waist or from a shoulder harness. They are battery-driven devices.

Proposed drug delivery routes using the EIP include the intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, intrathecal, and intraventricular routes. A heparinized saline solution may be used during an interruption of drug therapy to maintain catheter patency. The EIP is battery-powered and drug reservoir refilling is non-invasive. A catheter from the pump is attached to the desired access route for drug delivery.

OmniPod® is an external insulin pump sold by Insulet Corporation. This device has two separate components, a disposable "Pod" affixed to the skin that acts as the insulin pump and reservoir and a hand-held control unit referred to as a Personal Diabetes Manager or "PDM". The PDM also incorporates a FreeStyle blood glucose monitor (not continuous).

POLICY

Use of the external infusion pump (EIP) for the administration of the following drugs is considered medically necessary for selected patients on:

• morphine and other parenteral analgesics for treatment of severe, chronic cancer pain that is resistant to conventional therapy. Acceptable routes are subcutaneous (SC) and intravenous (IV);

• insulin for treatment of insulin-dependent diabetes mellitus in patients who cannot be controlled by intermittent dosing. Acceptable routes are SC and IV;

• heparin for treatment of severe thromboembolic disease that cannot be managed conventionally (e.g., complicated pregnancy). Acceptable routes are SC and IV;

• chemotherapeutics for treatment of cancer. Acceptable routes are stipulated in the drug labeling and might include either IV or intra-arterial (IA).

The OmniPod® external insulin pump includes a FreeStyle blood glucose monitor. Therefore, a separate glucometer is not elgible for coverage with the use of this system.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

9/1992: Approved by Medical Policy Advisory Committee (MPAC).

11/1997: Review and update approved by MPAC.

2/27/2002: Managed Care Requirements deleted.

4/26/2002: Type of Service and Place of Service deleted.

5/28/2002: Code Reference section updated.

11/5/2003: Code Reference section updated, HCPCS A4230-A4232 listed separately.

9/24/2004: Code Reference section updated, CPT code 62350, 62351, 62355 added, ICD-9 procedure code 03.90 added, ICD-9 diagnosis code 140 4th digit added 140.0, ICD-9 diagnosis 208.9 5th digit added 208.91, HCPCS A4222, A4230, A4231, A4232 “Note: See the Durable Medical Equipment (DME) medical policy for BCBSMS’ guidelines regarding accessories and medical supplies necessary for the effective functioning of covered durable medical equipment.” Added, HCPCS A4632 added, K0552, K0601, K0602, K0603, K0604, K0605 added.

3/24/2006: Coding updated. CPT4 2006 revisions added to policy.

3/28/2006: Policy reviewed, no changes.

12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions.

12/17/2007: Coding updated. CPT/HCPCS 2008 revisions added to policy.

7/21/2009: Description section updated to include OmniPod® information; policy statement updated to include separate glucometers are ineligible for coverage with the OmniPod® system. Code reference section updated: HCPC code E1399 added to covered table; notes added to codes A9274 and E0784.

12/31/2014: Added the following new 2015 HCPCS code to the Code Reference section: A4602.

08/28/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 444.0 to the fifth digit as 444.01 and 444.09.

04/13/2016: Policy guidelines updated to add medically necessary definition.

05/31/2016: Policy number L.1.01.407 added.

09/09/2016: Code Reference section updated to make correction: ICD-10 diagnosis code O22.0 should be O22.20.

09/30/2016: Code Reference section updated to add the following new ICD-10 diagnosis codes: E10.3521 - E10.3529, E10.3531 - E10.3539, E10.3541 - E10.3549, and E10.37X1 - E10.37X9.

12/30/2016: Code Reference section updated to add new 2017 HCPCS code A4225. Revised code description for HCPCS code K0552.

05/16/2018: Updated links in Code Reference section.

11/02/2018: Code Reference section updated to add new ICD-10 codes D04.111, D04.112, D04.121, and D04.122.

12/20/2019: Code Reference section updated to add new HCPCS code E0787 effective 01/01/2020.

10/14/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

10/18/2023: Policy reviewed; no changes.

12/03/2024: Policy reviewed. Policy statements unchanged. Sources updated.

SOURCE(S)

1. A search of literature was completed through the MEDLINE database for the period of January 1992 through May 1995. The search strategy focused on references containing the following Medical Subject Headings:

   • Infusion Pumps

   • Portable or External or Ambulatory

2. Blue Cross Blue Shield Association policy #1.01.08

3. Hayes Medical Technology Directory

4. https://www.anthem.com/dam/medpolicies/abcbs/active/guidelines/gl_pw_e002724.html

5. Research was limited to English-language journals on humans

6. TEC Evaluations 1989: p. 59

7. Uniform Medical Policy Manual, 4/1990

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.